Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU
New Template Issued To State Compliance With EU Data Protection Legislation
Executive Summary
Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.
You may also be interested in...
Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal
From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.
So Far So Good: EU Member States On ‘Limited’ Experience With Clinical Trial Portal
At a recent webinar on the EU Clinical Trial Information System (CTIS), representatives from different EU member states said the new system was working well and highlighted certain “good practices” for study sponsors to consider.
EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements
The European Commission wants to ensure that the content of dossiers filed under the EU Clinical Trial Regulation is harmonized to simplify the trial approval process. Any national requirements imposed by member states should have a clear legal basis.